NCT02496377

Brief Summary

Patients were recruited at the scheduled preoperative visit for hip or knee arthroplasty. If the haemoglobin (Hb) level was below 13 g/dl with no contraindication to iron supplementation the patients were randomized to the oral or intravenous (IV) group. The oral group received 160 mg ferrous glycine sulfate daily during the month prior surgery, associated with 3 epoetin alpha (EPO) injections (40 000 IU subcutaneous on day - 21, day - 14 and day-7). The IV group received ferric carboxymaltose 1000 mg IV in 15 minutes one month before surgery, associated with 3 EPO injections. Primary efficacy endpoint was the change in Hb level from the day of the preoperative visit to the day before surgery (day-1). Secondary endpoints comprised the Hb level on day 3 and 5 after surgery, allogenic transfusion during and after surgery, and the change in iron indices from the day of the preoperative visit to day - 1.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2016

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

2.1 years

First QC Date

June 19, 2015

Last Update Submit

January 21, 2019

Conditions

Allogenic TransfusionPerioperative AnaemiaKnee ArthroplastyHip Arthroplasty

Keywords

AnaemiaIron deficiencyFerric carboxymaltosePatient blood managementHip arthroplastyKnee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Compare Hb level after treatment with EPO associated with iron treatment by oral or intravenous route

    the day before surgery (day - 1)

Secondary Outcomes (3)

  • Hb level

    before iron treatment, then the day before surgery (day - 1) based on reference iron balance

  • number of red blood cells

    during surgery and 3 days after surgery

  • the change in iron indices

    before iron treatment and after iron treatment the day before surgery (day - 1)

Study Arms (2)

Group 1: Per Os Tardyferon

ACTIVE COMPARATOR

EPO associated with Iron per os tardyferon before surgery. The oral group received 160 mg ferrous glycine sulfate daily during the month prior surgery, associated with 3 epoetin alpha (EPO) injections (40 000 IU subcutaneous on day - 21, day - 14 and day-7).

Drug: ferrous glycine sulfate TardyferonDrug: Epoetin Alfa

Group 2: IV Ferinject

EXPERIMENTAL

EPO associated with Iron per IV Ferinject before surgery. The IV group received ferric carboxymaltose 1000 mg IV in 15 minutes one month before surgery, associated with 3 EPO injections.

Drug: Epoetin AlfaDrug: ferric carboxymaltose Ferinject

Interventions

ferrous glycine sulfate TardyferonDRUG
Group 1: Per Os Tardyferon
Epoetin AlfaDRUG
Group 1: Per Os TardyferonGroup 2: IV Ferinject
ferric carboxymaltose FerinjectDRUG
Group 2: IV Ferinject

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral prothetic orthopaedic surgery scheduled
  • age \> 18
  • weight \> 50 kg
  • hemoglobin rate: 10 g/dl ≤ Hb \<13 g/dl

You may not qualify if:

  • bilateral arthroplasty
  • EPO contraindication
  • generalized infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Lapeyronie - Département Anesthésie Réanimation A

Montpellier, 34295, France

Location

MeSH Terms

Conditions

AnemiaIron Deficiencies

Interventions

Epoetin Alfaferric carboxymaltose

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Philippe BIBOULET, MD, PhD

    Montpellier University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2015

First Posted

July 14, 2015

Study Start

August 29, 2014

Primary Completion

October 16, 2016

Study Completion

October 16, 2016

Last Updated

January 23, 2019

Record last verified: 2019-01

Locations

FR(1)